Ringing a Bell on the Final Day of Radiation Therapy in Improving the Memory of Distress in Cancer Patients

University of Southern California

Status: Completed

Conditions: Malignant Neoplasm; Distress

Treatments: Radiation: Radiation therapy; Other: Questionnaire Administration; Other: Memory Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02970617

NCI-2016-01259 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

OS-15-15 (Other Identifier)

Details and patient eligibility

About

This clinical trial studies how well ringing a bell on the final day of radiation therapy works in improving the memory of distress in cancer patients. Ringing a bell on the final day of radiation therapy may improve the memory of how painful the treatment was.

Full description

PRIMARY OBJECTIVES:

I. To determine if the simple act of ringing a bell at the end of radiotherapy can improve the retrospective evaluation of distress due to radiotherapy and other prior cancer therapy.

SECONDARY OBJECTIVES:

I. To measure the severity of patients' memory of distress from cancer treatment.

II. To assess the relationship between anxiety to actual distress and to remembered distress.

III. To assess the relationship between optimism-pessimism personality to actual distress and to remembered distress.

IV. To assess patient's cognitive dissonance reduction to actual distress and to remembered distress.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP A (No bell ringing): Patients undergo standard of care radiation therapy with or without chemotherapy.

GROUP B (Bell ringing): On the final day of standard of care radiation therapy, patients ring a bell in the clinic.

After completion of study, patients are followed up for 7 months.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of cancer
• Definitive radiation treatment with or without concurrent chemotherapy with curative intent; treatment prior to radiation therapy is acceptable (e.g. surgery, chemotherapy)
• Ability to understand and the willingness to sign a written informed consent; consents will be provided in English or Spanish
• Able to speak English or Spanish (questionnaires will be in English and Spanish)

Exclusion criteria

• Patients with either a malignant central nervous system (CNS)-primary cancer or with brain metastases; patients do not need to undergo brain imaging unless indicated per standard workup and management (e.g. advanced stage lung cancer receiving definitive therapy)
• Patients who will be receiving surgery or adjuvant chemotherapy within 1 month following radiation treatment
• Patients with widespread metastatic disease (> 3 distant metastases); patients with oligometastatic disease (=< 3 distant metastases) are allowed only if they are receiving definitive (curative) radiation therapy (RT) with or without chemotherapy

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

82 participants in 2 patient groups

Group A (no bell after final radiation)

Active Comparator group

Description:

Patients undergo standard of care radiation therapy with or without chemotherapy.

Treatment:

Radiation: Radiation therapy

Other: Questionnaire Administration

Group B (ring bell after final radiation treatment)

Experimental group

Description:

On the final day of standard of care radiation therapy, patients ring a bell in the clinic.

Treatment:

Radiation: Radiation therapy

Other: Memory Intervention

Other: Questionnaire Administration